St. Jude Receives FDA Approval

St. Jude Medical, Inc. (STJ) - Analyst Report received U.S. Food and Drug Administration (FDA) clearance for the launch of its EnSite Velocity Cardiac Mapping System. The system helps physicians more efficiently diagnose and guide therapy to treat abnormal heart rhythms. 

The EnSite Velocity Cardiac Mapping System is the leading cardiac mapping system used in minimally invasive electrophysiology procedures. The system consists of catheters with electrodes that are inserted into a cardiac chamber. These electrodes are then visualized by the system that records electrical information from the heart and displays it in a 3-D anatomical model. The anatomical models are known as maps that help physicians to diagnose and guide therapy for abnormal heart rhythms. 

The new EnSite Velocity Cardiac Mapping System enhances procedural efficiency and speed, thereby making it more user-friendly from set-up and operation to clinical application. The system is compatible with all diagnostic and ablation catheters, recording systems and energy sources used for ablation procedures. 

We think that the new approval will increase sales of St. Jude’s Atrial Fibrillation (AF) business which will eventually lead to overall top-line growth. The AF segment accounted for roughly 13% of the company’s sales in the second quarter of 2009. 

St. Jude is a leading medical device manufacturer that designs, manufactures and distributes medical devices to treat cardiovascular and neurological conditions. 

St. Jude Medical holds the #2 market position for ICDs and pacemakers behind Medtronic Inc. (MDT) - Analyst Report but ahead of Boston Scientific Corporation (BSX - Analyst Report). This segment is the company’s largest in terms of revenues. St. Jude also holds the #2 market position behind Medtronic in neuromodulation. 

Based on the company’s second quarter of 2009 results, we have assigned a Neutral rating to the stock.

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